Study Project Manager (Medical Affairs/Immunology/Oncology)

Responsibilities

• Independently lead Medical Affairs + Health Impact (MHI) funded research, including Externally Sponsored Collabs & Non-Interventional Studies (NIS) (single & multi-country) from inception to closure, in compliance with quality standards.
• Support strategic leadership of the Cross-Functional Team.
• Drive deliverables & timelines. Lead & manage meetings with stakeholders.
• Manage vendors, recruitment, CTMS & eTMF.
• Maintain Inspection Readiness.
• Identify, mitigate & manage risks.
• Develop & manage study materials.
• Provide training to stakeholders.
• Support EDC, IRT, & ePRO design specifications, user acceptance testing, plans & key risk indicators, & system management activities.
• Manage IP & study supplies. Support process improvement initiatives & serve as a subject matter expert &/or mentor.
• Education & Experience
• Must possess a Master's or foreign education equivalent & 2 years of clinical research work experience.
• Of work experience required, must have 2 years in each of the following:
• applying standard quality procedures to MHI research, including SOP, ICH/GCP, Global Regulations;
• working with ICFs, protocols, & amendments;
• functioning independently in a matrixed environment with teams in multiple time zones across the globe;
• using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;
• managing meetings (creating agendas, preparing minutes, or presenting);
• analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; &
• ensuring data is clean, documents are accurate to maintain inspection readiness.
• Alternatively, would accept a Bachelors or foreign education equivalent & 5 years of clinical research work experience.
• Of work experience required, must have 5 years in each of the following:
• applying standard quality procedures to MHI research, including SOP, ICH/GCP, Global Regulations;
• working with ICFs, protocols, & amendments;
• functioning independently in a matrixed environment with teams in multiple time zones across the globe;
• using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;
• managing meetings (creating agendas, preparing minutes, or presenting);
• analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; &
• ensuring data is clean, documents are accurate to maintain inspection readiness.
• Work experience may be gained concurrently. Would accept combination of education, training and work experience.
• Salary Range: $148,000.00 - $202,500.00 per year.
• Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com . Refer to Req ID: REF49790R
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• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

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